Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus (CCL)
Background: Corneal cross linking is a procedure that induces collagen cross linking of the corneal stroma due to release of reactive oxygen radicals upon activation of topically applied riboflavine A by UVA exposure. This procedure might be capable of reducing keratocouns progression.
Purpose: Although there are no randomised controlled trials on the effectiveness of corneal cross linking for the treatment of keratoconus it gains more and more importance in the general clinical setting. Therefore, the investigators started such randomised, placebo controlled, double blinded, multicenter trial to find out if this treatment is as effective as it promises to be.
Methods: Randomised, placebo controlled, double blinded, multicenter trial.
|Keratoconus||Procedure: Riboflavin/UVA crosslinking Procedure: Sham treatment||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Riboflavin Mediated Corneal Crosslinking for Stabilizing Progression of Keratoconus|
- Keratoconus progression [ Time Frame: 3 years ]
- Endothelial cell loss [ Time Frame: 3 years ]
|Study Start Date:||August 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Procedure: Riboflavin/UVA crosslinking
Removal of epithelium. Riboflavin eye drops. UVA exposure.
|Sham Comparator: 2||
Procedure: Sham treatment
Fluorescein eye drops. Exposure with blue light
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626717
|University Eye Hospital Freiburg|
|Freiburg, Baden-Württemberg, Germany, 79106|
|Principal Investigator:||Philip Maier, MD||University Eye Hospital, Freiburg|